Researchers find Inlyta/TACE safe, well-tolerated in Chinese patients with HCC

Issue: July 25, 2015

CHICAGO — In an ongoing phase 2 clinical trial, Inlyta and transarterial chemoembolization therapy was safe and yielded high response rates in Chinese patients with hepatocellular carcinoma, according to a poster presented at the ASCO Annual Meeting.

“An upregulation of [vascular endothelial growth factor receptor] mediated signal is frequent after [transarterial chemoembolization] for treatment of hepatocellular carcinoma,” Stephen Lam Chan, MBBS, MRCP, FHKCP, FHKAM, associate professor, department of clinical oncology, The Chinese University of Hong Kong, told Healio.com/Hepatology. “In this phase 2 study, it is hypothesized that the addition of axitinib, a potent antiangiogenic drug, to [transarterial chemoembolization] could improve patients’ outcomes by abolishing such signals after [transarterial chemoembolization] procedures.”

Chan and colleagues assigned 50 patients to receive 5 mg of Inlyta (axitinib, Pfizer) followed by transarterial chemoembolization (TACE) after 5 weeks of axitinib. Axitinib was withheld 24 hours before and resumed 24 hours after TACE. Patients were assessed every 2 months to determine if further TACE was required. Computed tomography imaging was performed every 8 weeks and TACE was only given if there was viable HCC and patients were suitable for TACE, according to the abstract.

The median follow-up was 21.6 months and the primary endpoint was 2-year survival rate.

Of the 50 patients, the median age was 61.8 years; median tumor diameter was 6.8 cm; and the median cycle of TACE given was two.

Overall, the median overall survival (OS) was 15.9 months (95% CI, 13.7-31.9) with a 2-year OS rate of 41.9%. The median time-to-progression was 10.4 months.

In 45 evaluable patients, 30 experienced a partial or complete response to treatment (68.2%).

“The combination is associated with a high response rate,” Chan said. “Six out of 50 patients had downstaging of tumor and underwent surgery, of which surgical specimen showed extensive necrosis. [In addition], the combination is safe with a low rate of grade 3 or above toxicities. The development of hypertension is associated with significantly better OS, indicating that antiangiogenic property was the key mechanism of action.”

Common toxicities greater or equal to grade 3 included: alanine aminotransferase elevation (40%), hypertension (24%) and hand-foot skin reaction (12%). Any grade of hypertension developed during the treatment period is associated with better OS (25 vs. 13.7 months; P = .03).

“The regimen is well-tolerated without significant safety concern,” the researchers concluded. “Selected patients could be converted to operable state after downstaging.”

A randomized study to further evaluate the regimen is currently being developed, according to Chan. – by Melinda Stevens

Reference:

Chan SL, et al. Abstract 4073. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.

Disclosures: Chan reports consulting for Novartis; he is on the speaker’s bureau for Sanofi; and receives travel, accommodations and expenses from Pfizer.